A Study of JNJ-87562761 in Participants With Relapsed or Refractory Multiple Myeloma

NCT06604715 | Recruiting Phase 1

• 2 other identifiers: 87562761MMY10012024-513439-25-00
• Study Type: interventional
• Target: 80
• Locations: 4 countries
• Sites: 15

Brief Summary

The purpose of this study is to determine the recommended phase 2 dose(s) (RP2D\[s\]) of JNJ-87562761 in Part 1 (dose escalation), and to determine the safety and tolerability at RP2D in Part 2 (dose expansion) in participants with multiple myeloma (MM) whose disease has come back after treatment (relapsed) or hasn't responded to treatment (refractory).

Conditions

Relapsed or Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (3)

• Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)

  DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.

  up to approximately 3 years

• Part 1 and 2: Number of Participants with Adverse Events (AEs)

  Number of participants with AEs will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

  up to approximately 3 years

• Part 2: Number of Participants with Clinically Significant Abnormal Laboratory Values

  Number of participants with clinically significant abnormal laboratory values (hematology or chemistry) will be reported.

  up to approximately 3 years

Secondary Outcomes (9)

• Serum Concentration of JNJ-87562761

  up to approximately 3 years

• Pharmacokinetic (PK) Parameters of JNJ-87562761

  up to approximately 3 years

• Number of Participants with Presence of Anti-JNJ-87562761 Antibodies

  up to approximately 3 years

• Percentage of Participants with Response

  up to approximately 3 years

• Percentage of Participants Who Achieve Very Good Partial Response (VGPR) or Better

  up to approximately 3 years

Study Arms (1)

JNJ-87562761

EXPERIMENTAL

Participants will receive JNJ-87562761 during the Part 1 (Dose escalation) to determine the recommended phase 2 dose (RP2D) regimen(s). The dose will be escalated sequentially until the RP2D regimen(s) have been identified. In Part 2 (Dose expansion) participants will receive JNJ-87562761 at the RP2D regimen(s) determined in Part 1.

Drug: JNJ-87562761

Interventions

JNJ-87562761 DRUG

JNJ-87562761 will be administered.

JNJ-87562761

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Relapsed, refractory multiple myeloma with measurable disease defined as: (a) Serum monoclonal paraprotein (M-protein) level greater than (\>)0.5 grams per deciliter (g/dL); or (b) Urine M-protein level \>200 milligrams per 24 hours (mg/24 hours); or (c) Light chain multiple myeloma: serum immunoglobulin free light chain (FLC) \>10 milligrams per deciliter (mg/dL) and abnormal serum immunoglobulin kappa-lambda FLC ratio
• Must have had prior therapy including a proteasome inhibitor, immunomodulatory agent and anti-CD38 therapy
• Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1
• Have an estimated glomerular filtration rate (eGFR), of \> 30 millilitres (mL)/min/1.73 meter square (m\^2) computed per 2021 chronic kidney disease epidemiology collaboration (CKD-EPI) creatinine equation
• While on study treatment and for 6 months after the last dose of study treatment, a participant must: (a) Not breastfeed or be pregnant; (b) Not donate gametes (that is, eggs or sperm) or freeze for future use for the purposes of assisted reproduction; (c) Wear an external condom

You may not qualify if:

• Active plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or immunoglobulin light chain amyloidosis
• Prior allogeneic transplant within 6 months before the start of study treatment administration or autologous transplant within 12 weeks before the start of study treatment administration
• Live, attenuated vaccine within 4 weeks before the first dose of study treatment
• Central Nervous System (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
• Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline level or to less than or equal to (\<=) Grade 1 (except alopecia, tissue post-RT fibrosis, or Grade \< 3 peripheral neuropathy)
• Received a cumulative dose of corticosteroids equivalent to greater than or equal to (\>=) 140 mg of prednisone within the 14-day period before the start of study treatment administration
• Prior antitumor therapy in the specified time frame prior to the first dose of study treatment: (Targeted therapy, epigenetic therapy, monoclonal antibody treatment, or treatment with an investigational drug or an invasive investigational medical device or conventional chemotherapy within 21 days, gene-modified adoptive cell therapy or treatment with anti-CD38 directed therapies within 3 months, proteasome inhibitor \[PI\] therapy or radiotherapy within 14 days, or immunomodulatory drug (IMiD) agent therapy within 7 days)
• Following medical conditions: pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency (HIV) infection (participants with a detectable viral load or low CD4 count), active hepatitis B or C infection, active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of study treatment, serious uncontrolled ongoing viral or bacterial or systemic fungal infection, cardiac conditions (myocardial infarction \<=6 months prior to enrollment, New York Heart Association stage III or IV congestive heart failure, et cetera \[etc.\])

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (15)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

The Catholic University of Korea Seoul St Marys Hospital

Seoul, 137 701, South Korea

RECRUITING

Hosp. Univ. Germans Trias I Pujol

Badalona, 08916, Spain

RECRUITING

Hosp Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Hosp Univ Fund Jimenez Diaz

Madrid, 28040, Spain

RECRUITING

Clinica Univ. de Navarra

Pamplona, 31008, Spain

RECRUITING

Hosp Clinico Univ de Salamanca

Salamanca, 37007, Spain

RECRUITING

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

RECRUITING

China Medical University Hospital

Taichung, 404, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, 70403, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 100225, Taiwan

RECRUITING

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 19, 2024
• Study Start: December 19, 2024
• Primary Completion (Estimated): November 3, 2027
• Study Completion (Estimated): November 15, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CA (2); KR (4); ES (5); TW (4)